Renewal of Marketing Authorisation
(Version 2.2, 29 January 2026)
The renewal of a marketing authorisation (hereinafter: renewal) is initiated by the marketing authorisation holder (MAH) by submission of an application to the Agency for Medicinal Products and Medical Devices (HALMED), at least nine months prior to the expiry of the marketing authorisation.
Premature submissions should be avoided, except in cases of earlier renewal due to harmonisation in accordance with paragraph 1 of Article 42 of the Ordinance on granting the marketing authorisation, as such renewal data may not be sufficiently up to date for HALMED to adopt a decision on the renewal.
The application for the renewal should be submitted in accordance with the Guideline of the Co-ordination Group for Mutual Recognition and Decentralised Procedure - Human Medicinal Products, (hereinafter: CMD(h)) which defines best practice on the processing of renewals and is published on the following link: CMD(h) BPG renewals (hereinafter: CMD(h) Guideline for renewal).
1. Standard renewal application
For Standard renewal application following documents should be submitted, in accordance with the section 3.6.1 of the CMD(h) Guideline for renewal:
1.1. cover letter for renewal available at Cover letter template for renewals,
1.2. electronic renewal application form available at eSubmisson/EU Electronic Application Forms,
1.3. proof of payment that includes proof that the fee for the procedure has been paid according to the HALMEDˈs fees.
2. Expanded renewal procedure with full documentation
In exceptional cases, there may be grounds for a submitting expanded renewal procedure with full documentation (section 3.7 of the CMDh Guideline for renewal) when a full documentation in accordance with Annex 3 of the CMDh Guideline for renewal should be submitted.
Product information
Marketing authorisation holders are required to submit changes to the product information, summary of product characteristics, package leaflet and labelling in order to ensure that the data in the product information is in line with current scientific information. If during the renewal of the authorisation is determined that significant changes to the product information are necessary, the MAH is required to submit a separate application for variation, in line with HALMEDˈs instructions for Variations.
In the renewal procedure, it is possible to accept minor changes to the product information (e.g. QRD harmonisation, harmonisation of the name for the pharmaceutical form, etc.) in which case it is necessary to submit the product information with the proposed changes (track changes version).
Once renewed, the MA shall be valid for an unlimited period unless the competent authority decides, on justified grounds relating to pharmacovigilance, including exposure of an insufficient number of patients to the medicinal product, to proceed with one additional five-year renewal.
The renewal procedure is set out in the following legislation:
